FDA Regulations Submissions

Course Description

This course will give the student the fundamental knowledge of FDA regulations as they apply to medical devices and pharmaceutical products and the documentation needed for such approval. The code of Federal Regulations will be utilized with emphasis on CFR 21, FDA compliance, ICH guidelines for international harmonization and Good Clinical Practice (GCP), investigator study files, FDA audits and Adverse Event reporting.

Learning Outcomes

  • Evaluate proposed products for appropriate FDA regulatory jurisdiction.
  • Understand the Code of Federal Regulation as it applied to pharmaceutical and medical devices.
  • Understand the regulatory pathway that will be necessary to follow for product approval.
  • Develop effective regulatory submission strategies for timely FDA product review.
  • Develop a master file for meeting FDA regulations.
  • Understand and evaluate good clinical practice (GCP).
  • Ensure clinical trial design, conduct and documentation are in compliance with GCP.
  • Be able to identify and understand adverse events with appropriate reporting.
  • Be able to write appropriate documents for FDA approval of a new drug or medical device.
  • Develop a standard operating procedures (SOP).
  • Develop and implement compliance documentation.
  • Understand labeling of a product or device.

Why Choose National University?

We’re proud to be a veteran-founded, San Diego-based nonprofit. Since 1971, our mission has been to provide accessible, achievable higher education to adult learners. Today, we educate students from across the U.S. and around the globe, with over 200,000 alumni worldwide.

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Study when and where it’s convenient for you with evening, weekend, and 100% online classes.

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Apply or transfer any time. Classes start monthly, and applications are accepted year round.

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